Protocol summary

Study aim
Determining the Effect of Training and Implementation Suction Technique Standards on Neonatal Clinical Outcomes in a Specialized Intensive Care Unit in a specialist Hospital
Design
Clinical trial with control group Nurses sample size based on census Sample size for neonate 21
Settings and conduct
The hospital section of the Akbar Hospital in Mashhad is a sampling site and nurses and neonates with entry criteria enter the study. All forms and information are recorded by the researcher.
Participants/Inclusion and exclusion criteria
Entry criteria: All neonatal admitted to hospital during the first 28 days of life in the special department of neonatal intensive care unit in a specialist hospital As well as for assessing the performance of all nurses working in PICU in a specialist hospital Based on the census Exit criteria: If the neonate was under 24 hours intubated, this form was removed from the file and removed from the study. Also, if the neonate was intubated more than a week old, information after the 7th day is no longer required.
Intervention groups
Main intervention: Training and implementation of standards for neonatal suction technique First, we believe that the control group's data collection site is collected and lice are trained to nurses during the conduct of the neonatal suctioning workshop in Gaidline, and then the information of the intervention group is collected. The performance of the nurses is measured before and after the training.
Main outcome variables
Gauge indicators include blood pH and Pao2 size and Paco2 size Pulmonary hemorrhage Nurses performance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181118041693N1
Registration date: 2019-01-26, 1397/11/06
Registration timing: retrospective

Last update: 2019-01-26, 1397/11/06
Update count: 0
Registration date
2019-01-26, 1397/11/06
Registrant information
Name
Akram Ahmadian moghaddam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
ahmadianma941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-01, 1396/11/12
Expected recruitment end date
2019-01-02, 1397/10/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of teaching and implementation of standards of neonatal suction technique on nurses' performance and neonatal clinical outcomes in intensive care unit in a specialist hospital
Public title
The effect of teaching and implementation of standards of neonatal suction technique on nurses' performance and neonatal clinical outcomes in intensive care unit in a specialist hospital
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Entry criteria: All neonatals admitted to hospital during the first 28 days of life in the special department of neonatal intensive care unit in a specialist hospital As well as for assessing the performance of all nurses working in PICU in a specialist hospital.
Exclusion criteria:
neonatal less than 34 weeks and up to 28 days
Age
To 28 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 21
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Ebne_sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2018-01-31, 1396/11/11
Ethics committee reference number
IR.MUMS.REC.1396.340

Health conditions studied

1

Description of health condition studied
Neonatal suction
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Nurses performance
Timepoint
Beginning of the study and after the training of neonatal's suctioning
Method of measurement
Questionnaire and View

2

Description
Gauge indicators include blood pH and Pao2 size and Paco2 size
Timepoint
Beginning of the study and after the training of neonatal's suctioning
Method of measurement
Values recorded by the laboratory

3

Description
Incidence of pulmonary hemorrhage
Timepoint
Beginning of the study and after the training of neonatal's suctioning
Method of measurement
See in the chest photo and see direct blood in the chest tube or baby chest tube

Secondary outcomes

1

Description
The frequency of need for suction
Timepoint
Beginning of the study and after the training of neonatal's suctioning
Method of measurement
View and register everyday

2

Description
Number of re_intubasion
Timepoint
Beginning of the study and after the training of neonatal's suctioning
Method of measurement
View and register everyday

3

Description
Occurrence of atelectasis
Timepoint
Beginning of the study and after the training of neonatal's suctioning
Method of measurement
View and register everyday

Intervention groups

1

Description
Intervention group: 21 neonates were admitted during the first 28 days of life in the special department of neonatal intensive care unit of a specialist hospital
Category
Other

2

Description
Intervention group: All nurses working at PICU of specialist hospital
Category
Other

3

Description
Control group: Intervention group: 21 neonates were admitted during the first 28 days of life in the special department of neonatal intensive care unit of a specialist hospital
Category
Other

4

Description
Control group: All nurses working at PICU of specialist hospital
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Akbar Hospital
Full name of responsible person
Rezaeian Aramesh
Street address
Mashhad, Shahid Kaveh Blvd, against Shahid Kaveh 14
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3871 3801
Fax
+98 51 3870 9201
Email
rezaeiana@mums.ac.ir
Web page address
http://akbar.mums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Rezaeian Aramesh
Street address
Ebne_Sina
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
+98 51 3859 7313
Email
rezaeiana@mums.ac.ir
Web page address
http://nurse.mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Rezaeian Aramesh
Position
Master's Degree
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ebne_Sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
+98 51 3859 7313
Email
RezaeianA@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Rezaeian Aramesh
Position
Master's Degree
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ebne_Sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
+98 51 3859 7313
Email
RezaeianA@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Rezaeian Aramesh
Position
Master's Degree
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ebne_Sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
+98 51 3589 7313
Email
RezaeianA@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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